BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HYDROTHERMABLATOR PROCEDURE SET

    MDR report key: 1346217 · Received December 12, 2008

    Report

    Report Number
    3005099803-2008-07131
    Event Type
    Malfunction
    Date Received
    December 12, 2008
    Date of Event
    November 13, 2008
    Report Date
    November 13, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    MNB
    PMA / PMN Number
    P000040
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE LOT NUMBER OF THE SUSPECT DEVICE IS UNKNOWN; THEREFORE, THE MANUFACTURE AND EXPIRATION DATES CAN NOT BE DETERMINED. THE SUSPECT DEVICE HAS BEEN DISPOSED. A DEVICE EVALUATION WILL NOT BE PERFORMED; THEREFORE, THE CAUSE OF THE REPORTED EVENT IS UNDETERMINED.

    Description of Event or Problem · 1

    BOSTON SCIENTIFIC CORPORATION WAS INFORMED THAT DURING A HTA PROCEDURE, USING A HYDROTHERMABLATOR PROCEDURE SET, FLUID LOSS ALARMS WERE RECEIVED. THE FIRST FLUID LOSS ALARM OCCURRED AT 81 DEGREE C (RATE OF LOSS WAS 10 CC AT 3 CC PER MINUTE). THE PHYSICIAN NOTICED SOME MOISTURE AT CERVIX AND PLACED A TENNACULUM AND CONTINUED WITH THE PROCEDURE. APPROXIMATELY 5 MINUTESS INTO THE ABLATION THEY RECEIVED A SECOND FLUID LOSS ALARM (RATE OF LOSS WAS 10CC AT 1 CC PER MINUTE). THE PHYSICIAN REPOSITIONED THE TENNACULUM AND COMPLETED THE CASE WITHOUT ANY OTHER FLUID LOSSES. THE VAGINA AND CERVIX SHOWED NO BLANCHING AND NO SIGNS OF BURN. PATIENT IS REPORTED TO BE "FINE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HYDROTHERMABLATOR PROCEDURE SET MNB BOSTON SCIENTIFIC CORPORATION M006560201 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK